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AbbVie Reports Third-Quarter 2013 Financial Results
Date:10/25/2013

Key Events from the Third Quarter

  • In the quarter we made significant progress toward the completion of our Phase 3 interferon-free hepatitis C program.  AbbVie's Phase 3 program, which includes six trials in more than 2,000 patients and trial sites in 30 countries, represents the largest interferon-free HCV registrational program conducted to date.  This comprehensive program was designed to characterize the performance of AbbVie's 3-DAA regimen across genotype 1 populations and includes independent studies in difficult to treat patients.  We expect to begin reporting the initial results from these studies in the fourth quarter and into early next year, supporting registration submissions in the second quarter of 2014.  
  • New data from AbbVie's Phase 2 hepatitis C clinical development program will be presented at the Liver Meeting, the annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Washington, D.C., beginning next week.  Abstracts presented will include additional analyses from the Phase 2b AVIATOR study. The data examine sustained virologic response (SVR) concordance, patient adherence to the regimen, patient reported outcomes and the impact of ribavirin dose reduction. 
  • AbbVie presented Phase 2 data evaluating the efficacy of HUMIRA in patients with hidradenitis suppurativa (HS), a chronic inflammatory skin disease, at the European Dermatology and Venereology (EADV) meeting in Istanbul, Turkey.  The post-hoc analysis found that HUMIRA induced a significant response rate in adult patients with moderate-to-severe HS at week 16 versus placebo. HUMIRA is the first therapy to enter Phase 3 studies in HS.  Two fully-enrolled Phase 3 clinical trials are underway to evaluate the safety and efficacy of HUMIRA in approximately 600 adult HS patients.
  • AbbVie recently initiated a large single-agent study of our Bcl-2 inhibitor, ABT-199, in previously-treated
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